MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING

Catalog Number	24355
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A hospital alleged 3m¿ ranger¿ high flow warming set (model 24355) leaked at the heat exchanger on two separate devices.No patient or staff injury was alleged.
Additional Manufacturer Narrative
In accordance with 21 cfr 803 report number 2400100000-2022-8105 was received through fda's medwatch program.Product has been discarded; therefore, not returned to 3m¿ for analysis.3m¿ is unable to verify the leak, identify exact location and root cause without the sample.3m¿ will continue to monitor.

• Brand Name: 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET
• Common Device Name: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NYPRO PRECISION ASSEMBLIES; sor juana ines de la cruz; cd. industrial; tijuana, 22444 ; MX 22444
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15107299
• Report Number: 2110898-2022-00049
• Device Sequence Number: 4588203
• Product Code: BSB
• UDI-Device Identifier: 00707387781477
• UDI-Public: 00707387781477
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2024
• Device Catalogue Number: 24355
• Device Lot Number: HX9099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown